Validation, Data & Analytics Specialist

Title: Validation, Data & Analytics Specialist Location: New Brunswick, NJ (Hybrid) Job Description - Validation, Data & Analytics, Audit, and Business/Product Analysis Experience: 13+ Role Summary This role combines expertise in Validation, Data & Analytics. Audit Readiness, and Business/Product Analysis, supported by strong capabilities in strategy, change management, continuous process improvement, and citizen development. The position is responsible for enabling high-quality, compliant data-driven, and efficient business operations through structured analysis, validation, process excellence. and stakeholder facilitation. Primary Responsibilities 1. Validation (CSV/CSA/Automation Validation) Perform end-to-end validation of systems, tools, automations, and analytics workflows in alignment with regulatory expectations and internal quality frameworks. Develop validation deliverables (e.g., URS, risk assessments, validation plans, test scripts, traceability matrices, reports). Ensure validated state through periodic review, change control, and documentation management. Support audit readiness by ensuring validation evidence, controls, and documentation meet compliance standards. 1. Analytics & Data (Analysis, Engineering, Visualization) Conduct advanced data analysis to derive insights and support business decision-making. Build and optimize data pipelines, data models, and structured datasets for reporting and analytics use cases. Design dashboards, visualizations, and KPI frameworks to support operational and strategic visibility. Perform data profiling, data quality assessment, and data integrity reviews across systems. 1. Audit (Internal, External, Compliance) Support internal/external audits through documentation review, evidence preparation, and control assessment. Identify audit findings, gaps, and remediation actions; drive follow-up and closure. Ensure processes, systems, and data adhere to regulatory and compliance requirements. 1. Business & Product Analysis Gather and analyze business requirements, user needs, and system expectations. Translate business needs into functional specifications, user stories, and acceptance criteria. Support product roadmap development, feature prioritization, and release planning. Facilitate alignment between business users, technical teams, and leadership. Secondary Responsibilities Strategy/Business Case Development • Develop business cases to justify new initiatives, tools, automation, or process optimizations. • Conduct cost-benefit, ROI, and impact analyses to support strategic decisions. Change Management • Support organizational change through communication plans, stakeholder engagement, and readiness assessments. • Drive adoption of new tools, processes, and systems. Communication • Prepare clear communication materials status reports, executive summaries, presentations, and training assets. • Facilitate cross-functional workshops and stakeholder discussions. Project Management • Lead or support project planning, risk management, execution monitoring, and status tracking Coordinate cross-functional teams to ensure timely delivery of milestones. Facilitation • Conduct meetings, workshops, and working sessions for process mapping, requirements gathering, or prioritization • Guide SMEs through structured problem-solving and decision-making activities. UI/UX & Citizen Development • Contribute to UI/UX design thinking activities to enhance user experience. • Utilize low-code/no-code citizen development tools to build prototypes, automations, and workflow optimizations. Continuous Process Improvement • Lead Lean/Process Excellence initiatives to streamline workflows and eliminate inefficiencies • Conduct process mapping, root cause analysis, and performance assessments. • Implement improvements aligned to operational excellence and compliance needs. Skills & Qualifications • Strong grounding in validation (CSV/CSA), data analysis, and audit principles. • proficiency in analytics platforms, visualization tools, and data engineering concepts. • Experience in business analysis, requirements gathering, and stakeholder communication. Familiarity with Lean/Process Excellence methodologies and process documentation tools. • Strong facilitation, communication, and project coordination skills • Experience with low-code/no-code citizen development tools (e.g., PowerApps, Alteryx,Appian). • Ability to work in cross-functional, high-complexity environments.